MAUDE Adverse Event Report: ETHICON INC. TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Lot Number 3936368

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Incontinence (1928); Pain (1994); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Component code: g07002 ¿ device not returned.Related events captured via 2210968-2024-01820, 2210968-2024-01821.

Event Description

It was reported that a patient underwent a sling procedure on (b)(6) 2021 and mesh was implanted.The patient reported that in the wake-up room, they couldn't feel the left leg anymore.In the days following the operation, the patient felt pain inside the thighs above the adductors and still had urine leakage.The patient understood that it was pain in the obturator muscles and pain in the stomach.When putting on cream for post-operative healing, the patient felt something rough in the back of the vagina.The strip punctured the vagina.The patient had surgery and the surgeon cut the end of the strip.The pains did not go away, nor discomfort during sex.The piece of strip was analyzed and contaminated with a bacterium "streptococcus anginous multi-sensitive".From this operation, the patient had trouble taking long walks.Some days, the patient limped and stabbed in the stomach.The patient felt the strip all the time in the lower abdomen.The patient reported currently experiencing obturator muscle pain, leg pain with feeling of cramps, stomach pain, pain during sexual intercourse, urinary leakage always present and bacteria present many weeks despite treatment.Then the strip was removed by another surgeon on (b)(6) 2023.The operation was difficult but the strip was removed.The stomach pain has disappeared.The patient still has pain in the obturator muscles especially the right, and electric blows and cramps in the legs especially the right.The patient has done tests and it's not circulatory pain.Some movements hurt and intensive walking also triggers pain in the right shutter.No further information is available as the reporter contact details were not disclosed.

• Brand Name: TENSION FREE VAGINAL TAPE - OBTURATOR UNKNOWN PROD
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18769531
• MDR Text Key: 336128717
• Report Number: 2210968-2024-01822
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K033568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 3936368
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention